The goal: Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex.
The challenge: To engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product.
The outcome: Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to the clinic on time.
About Florida Biologix
Aseptic fill is only one small part of our business. Florida Biologix is a phase 1–2 biologics development, manufacturing, and testing organization that offers a wide range of services to the biotechnology industry. FB will overcome scientific challenges with scalable solutions for phase 1–2 and beyond; provide exceptional customer service with clear and honest communication; and ensure client manufacturing process ownership of high-quality GMP products. You can trust us to develop, produce, test, and/or fill CGMP-compliant biopharmaceutical clinical trial material on time and at an outstanding value.
A Full Range of Services in a State-of-the-Art Facility
FB Services Include
- cell line engineering and CGMP cell banking
- upstream and downstream processes design
- QC assay development and qualification
- CGMP production/purification of proteins expressed in mammalian cells (MAbs, recombinant proteins, enzymes, vaccines, other biomolecules)
- aseptic filling (nonhazardous small molecules, nucleic acids, proteins)
- product characterization and testing
- regulatory support.
Our 23,000-ft2 GMP multiproduct facility was designed and built with best-in-class equipment to provide timely, low-cost, high-quality, CGMP-compliant products. Our product development labs are in the adjacent building.
Individual Attention from an Experienced Team
Our people are not only deeply experienced in biopharmaceutical manufacturing and testing, but we are also approachable, trustworthy, and believe that the best way to build long-term relationships with our clients is through open communication. We know what it takes to get a product into the clinic and eventually to market. This explains why 95% of our clients say they would work with us again or refer us to others.
Highest quality at a Competitive Price
Quality is paramount in our business, and you will find it at every level of our organization. In-house quality control and quality assurance means your product will be appropriately characterized, tested, and released. Our operational model, location, and affiliations keep costs low — and we pass this savings to you.
Chris Aytug is director of marketing and sales at Florida Biologix, 13702 Innovation Drive, Alachua, FL 32615; 877-765-7676; firstname.lastname@example.org; www.floridabiologix.ufl.com.